MAUDE Adverse Event Report: CAREFUSION, INC ILLINOIS (TJ) NEEDLE ASPIRATION 15GA; BONE MARROW COLLECTION/TRANSFUSION KIT

Model Number	TIN3015
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.
Event or Problem Description
The tip of the needle was bent during biopsy.According to the nurse, the tip of the needle has been longer than the steering, which may have caused the needle to bend.This has occurred approx.20 times.
Event or Problem Description
The tip of the needle was bent during biopsy.According to the nurse, the tip of the needle has been longer than the steering, which may have caused the needle to bend.This has occurred approx.20 times.Please see answers below from distributor: hi (b)(6), we have supplied these batch numbers to kuopio: 1374720; 60 ea in (b)(6) 2020.1372717; 50 ea in (b)(6) 2020.1350086; 50 ea in (b)(6) 2020 and 30 ea in (b)(6) 2020.Patient impacted; yes, sample has been unsuccessful and therefore the procedure has been done once more.No serius injury.No erroneous results.No additional medical intervention.No other safety issues.According to my experience it seems that mandrine is too short compared to needle, manufacturing failure.According to customer information, total number of affected needles is 20 ea.Please, send replacement needles to: pharmanova oy; linnankoskenkatu 32; fi-06100 porvoo; finland.Best regards, (b)(6).
Additional Manufacturer Narrative
(b)(4).Follow up emdr for device evaluation: two photos were provided to our quality team for investigation.Through visual inspection, the needle is observed to be bent, verifying the reported incident.A review of the internal manufacturing device record and raw material history files for the reported lot 0001350086 was performed and no recorded quality problems or rejections related to this incident were found.Based on the quality team's investigation and without the physical sample to further evaluate, we cannot identify a root cause at this time.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.H3 other text: see manufacturer narrative.

• Brand Name: ILLINOIS (TJ) NEEDLE ASPIRATION 15GA
• Common Device Name: BONE MARROW COLLECTION/TRANSFUSION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 11174422
• Report Number: 1625685-2021-00004
• Device Sequence Number: 2551063
• Product Code: LWE
• UDI-Device Identifier: 10885403043796
• UDI-Public: (01)10885403043796
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K930217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: TIN3015
• Device Catalogue Number: TIN3015
• Device Lot Number: 0001350086
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 08/11/2021
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other